RecruitingPhase 1Phase 2NCT05278208

Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors

Phase I/II Study of Lutathera in Patients With Recurrent and/or Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET


Sponsor

Nationwide Children's Hospital

Enrollment

65 participants

Start Date

Nov 21, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \<12 years (Phase I) or 12 to \</=39 years (Phase II) to test its safety and efficacy, respectively. Funding Source - FDA OOPD (grant number FD-R-0532-01)


Eligibility

Min Age: 4 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study tests a radioactive drug called Lutathera in children, teens, and young adults (up to age 39) with high-grade brain tumors (such as glioblastoma) or meningioma that have come back or stopped responding to standard treatment. Lutathera targets tumors that have a specific protein on their surface, delivering radiation directly to cancer cells. **You may be eligible if...** - You are between 4 and 39 years old (age range varies by study phase) - You have a high-grade brain tumor or meningioma that has recurred or not responded to standard therapy - Your tumor shows uptake on a special scan (DOTATATE PET), confirming it has the target protein - Your overall health and organ function are good enough to tolerate treatment **You may NOT be eligible if...** - Your cancer has spread to the bone marrow - You have a very large tumor causing dangerous brain swelling - You have type 1 diabetes - You are breastfeeding - You are currently receiving other anti-cancer treatments Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGLUTATHERA® (Lutetium Lu 177 dotatate)

Lutathera: IV administration maximum dose of 200 mCi once every 8 weeks (one cycle) for total of 4 cycles (8 months)


Locations(4)

Children's Hospital Colorado

Aurora, Colorado, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

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NCT05278208


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